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510(k) Data Aggregation

    K Number
    K102625
    Device Name
    VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
    Manufacturer
    VEGA TECHNOLOGIES, INC.
    Date Cleared
    2011-06-10

    (270 days)

    Product Code
    BZD, BTT
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    VEGA TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VEGA CPAP System/Heated Humidifier, models CP-03 delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only. The device is intended for use in the home or hospital/institutional environment on adult patients.
    Device Description
    The VEGA CPAP System/Heated Humidifier, models CP-03 is a smaller and lighter AC -powered, micro processor-controlled, and blower-based system that generates positive airway pressure from 3 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface(mask). The CPAP device may also be used with VEGA Heated Humidifier that has been designed to be compatible with the CPAP and controlled from the CPAP. The basic functional and performance characteristics of the VEGA CPAP System/Heated Humidifier are completely similar to the predicate device, the Respironics REMstar Plus CPAP System/REMstar Heated Humidifier(K010263).
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    K Number
    K102934
    Device Name
    INFRARED EAR THERMOMETER, MODEL IR-04MT
    Manufacturer
    VEGA TECHNOLOGIES, INC.
    Date Cleared
    2011-01-14

    (102 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    VEGA TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Ear Thermometer, models IR-04MT are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.
    Device Description
    The Infrared Ear Thermometer, models IR-04MT is a handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) – controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared. This system uses a 3.0 V DC battery(2xAAA batteries) for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of IR-04MT, they were designed and verified according to the US standard ASTM E 1965-2003.
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    K Number
    K102626
    Device Name
    VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01
    Manufacturer
    VEGA TECHNOLOGIES, INC.
    Date Cleared
    2010-11-12

    (60 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    VEGA TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VEGA Medical Suction Equipment, model SU-01/SU-DC01 is a device used to remove fluids from airway or respiratory support system and infectious materials from wounds.
    Device Description
    The VEGA Medical Suction Equipment, model SU-01/SU-DC01 is a portable AC powered suction pump. It consists of a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, and suction tube. The device is designed and manufactured to comply with IEC 60601-1. IEC 60601-1-2, and ISO 10079-1.
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    K Number
    K041516
    Device Name
    DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
    Manufacturer
    VEGA TECHNOLOGIES, INC.
    Date Cleared
    2004-09-08

    (96 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    VEGA TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digital Thermometer, models MT-XX8 and MT-XX9 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be measurement of oral, axially and rectal temperature.
    Device Description
    The Digital Thermometers, models MT-XX8 and MT-XX9, are the electronic themometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) control instead of programmable control. Basically MT-XX8 and MT-XX9 have the same control and only the different measuring range caused by some small different design in IC circuit. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display.
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    K Number
    K031413
    Device Name
    VIGORMIST COMPRESSOR NEBULIZER
    Manufacturer
    VEGA TECHNOLOGIES, INC.
    Date Cleared
    2003-10-07

    (155 days)

    Product Code
    BTI, CAF
    Regulation Number
    868.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    VEGA TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VigorMist Compressor is intended to be used with a compatible pneumatic nebulizer (specifically the W estMed V ixOne) t o c onvert c ertain inhalable drugs into an aerosol form for inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The device is intended for the home care market. It is intended for use with a single adult, pediatric, or infant patient.
    Device Description
    The VigorMist™ Compressor is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer. It measures 11 7/8" x 7 1/8" x 4 1/2" and weights 4.6 lbs. The device has a thermal protector that will automatically shut off the device when overheated. The operating components are located internally. The compressor, some minor wiring and exhaust/intake tubing are located inside .. External components include a switch, filter with housing, AC cord and cover or accessories compartment. The accessories coming with the compressor include a nebulizer, Air tube and mouthpiece.
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    K Number
    K002831
    Device Name
    VEGA ULTRASONIC NEBULIZER
    Manufacturer
    VEGA TECHNOLOGIES, INC.
    Date Cleared
    2001-05-23

    (254 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    VEGA TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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